(88 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical components and performance characteristics of a PAP mask, with no mention of AI or ML.
No.
The device is a mask accessory for PAP therapy, not a therapeutic device itself.
No
This device is a PAP mask intended to facilitate PAP therapy, which is a treatment, not a diagnostic procedure. Its performance evaluation focuses on physical and material properties, not diagnostic accuracy.
No
The device description clearly outlines physical components (cloth cushion, headgear, elbow swivel connector) and the performance studies focus on material and physical properties, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an interface for Positive Airway Pressure (PAP) therapy. This is a therapeutic device used to deliver air pressure to a patient's airway.
- Device Description: The description details a mask, headgear, and connector – components of a respiratory support device.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to gain diagnostic information. This device is a therapeutic device used for delivering treatment.
N/A
Intended Use / Indications for Use
The SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. This mask is intended for single-patient reuse in the home and in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg).
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The SleepWeaver Anew Full Face Soft Cloth PAP Mask consists of a cloth cushion, headgear, and a 90° elbow swivel connector with anti-asphyxia valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients greater than 66 lbs (30 kg)
Intended User / Care Setting
single-patient reuse in the home and in the hospital/institutional environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing for the SleepWeaver Anew Full Face Soft Cloth PAP Mask included the following tests or evaluations:
- Material evaluation; .
- Product performance testing: .
- Physical Dead Space:
- Anti-Asphyxia Resistance: 0
- Anti-Asphyxia Operation: 0
- Pressure Drop: 0
- Carbon Dioxide Washout: and
- Leak Rate. 0
- . Connector performance testing;
- Product usability evaluation; t
- Biocompatibility: .
- Patient Contract Duration: Permanent
- Gas Pathway (External Communicating) Components 90° swivel with anti- aspliyxia valve, mask body material, nasal interface, and internal surface of the oral interface. The materials in these components have been used in legally marketed devices. Biocompatibility requirements met.
- Surface Contact (Skin) Components: Headgear / mask wings . external surface of the oral interface. The headgear material has been used in legally marketed devices: The material used for the external surface of the oral interface represents a material not previously used in a legally marketed device and was, subsequently, subjected to Cytotoxicity, Sensitization, and Irritation testing according to the guidelines set by ISO 10993-1 and the EDA G95-1 memorandum: Biocompatibility requirements met.
- Reliability:
- Packaging: .
- Accessory interfacing: .
- Storage testing: .
- Labeling review; and .
Design analysis.
In all instances, the SleepWeaver Anew Full Face Soft Cloth PAP Mask functioned as intended and results of each test observed were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SleepWeaver élan Nasal CPAP Mask Circadiance, LLC, Mirage Quattro ResMED, Ltd.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
MAY 2 4 2013
Circadiance LLC SleepWeaver Anew Full Face Soft Cloth PAP Mask
David Groll CEO David.Groll@Circadiance.com
Circadiance, LLC 1060 Corporate Lane Export, PA 15632 Phone: (724) 858-2837 Facsimile: (412) 202-4583
Contact Person: Ryan T. Kasun, (724-327-0230, x201), rkasun@raqasolutions.com
Date Prepared: February 18 2013
Name of Device and Name/Address of Sponsor
SleepWeaver Anew Full Face Soft Cloth PAP Mask
Common or Usual Name
Full Face PAP Mask
Classification Name
BZD - ventilator, non-continuous (respirator); 21 CFR 868.5905
Predicate Devices
SleepWeaver élan Nasal CPAP Mask Circadiance, LLC Common/Usual Name: Nasal CPAP Mask Classification: 21 CFR 868.5905 Product Code: BZD Panel: Anesthiesiology
Mirage Quattro ResMED, Ltd. Common/Usual Name: Full Face PAP Mask Classification: 21 CFR 868.5905 Product Code: BZD Panel: Anesthiesiology
Intended Use / Indications for Use
Circadiance, LLC
1
The SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. This mask is intended for single-patient reuse in the home and in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg).
Technological Characteristics
The SleepWeaver Anew Full Face Soft Cloth PAP Mask consists of a cloth cushion, headgear, and a 90° elbow swivel connector with anti-asphyxia valve.
The optional SleepWeaver FeatherWeight tube may be used with this mask, but it remains outside the scope of this submission as it has been previously cleared by its inclusion in K120757.
Performance Data
Performance testing for the SleepWeaver Anew Full Face Soft Cloth PAP Mask included the following tests or evaluations:
- Material evaluation; .
- Product performance testing: .
- Physical Dead Space: ্র
- Anti-Asphyxia Resistance: 0
- Anti-Asphyxia Operation: 0
- Pressure Drop: 0
- Carbon Dioxide Washout: and ం
- Leak Rate. 0
- . Connector performance testing;
- Product usability evaluation; t
- Biocompatibility: .
- Patient Contract Duration: Permanent o
- Gas Pathway (External Communicating) Components 90° swivel with anti-্রে aspliyxia valve, mask body material, nasal interface, and internal surface of the oral interface. The materials in these components have been used in legally marketed devices. Biocompatibility requirements met.
- Surface Contact (Skin) Components: Headgear / mask wings . external с surface of the oral interface. The headgear material has been used in legally marketed devices: The material used for the external surface of the oral interface represents a material not previously used in a legally marketed device and was, subsequently, subjected to Cytotoxicity, Sensitization, and Irritation testing according to the guidelines set by ISO 10993-1 and the EDA G95-1 memorandum: Biocompatibility requirements met.
- Reliability:
- Packaging: .
- Accessory interfacing: .
- Storage testing: .
- Labeling review; and .
2
. Design analysis.
In all instances, the SleepWeaver Anew Full Face Soft Cloth PAP Mask functioned as intended and results of each test observed were as expected.
Circadiance, LLC
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2013
Mr. David Groll Chief Executive Officer Circadiance, LLC 1060 Corporate Lane Export, PA 15632
Re: K130481
Trade/Device Name: SleepWeaver Anew Full Face Soft Cloth PAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: April 26. 2013 Received: May 6, 2013
Dear Mr. Groll: ·
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Groll
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Ruan, DDS, AIA
Digitally signed by Mary S. Runner - 5
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner -
5, 0.9.2342.19200300.100.1.1=1300087950
Date: 2013.05.23 14:59:36 -04'00
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Traditional 510(k) Tab 5 - Indications For Use Statement SleepWeaver Anew Full Face Soft Cloth PAP Mask
Indications for Use Statement
K130481 510(k) Number (if known):
Device Name: SleepWeaver Anew Full Face Soft Cloth PAP Mask
Indications for Use:
The SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. This mask is intended for single-patient reuse in the home and in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg).
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Amv | · K. Levelle ··
STATE |
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| | 11 12/
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| 2013.05:2 | 04'00'
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the same of the states of the states
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(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
K130481 510(k) Number:
Circadiance, LLC
February 22, 2013
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